08:30 AM EDT, 07/15/2025 (MT Newswires) -- ProKidney ( PROK ) said Tuesday that the US Food and Drug Administration has confirmed that the estimated glomerular filtration rate slope can be used as an endpoint to support a biologics license application for rilparencel in patients with chronic kidney disease and type 2 diabetes under the accelerated approval pathway.

The regulator has also confirmed that an ongoing phase 3 trial can be used to support applications for both accelerated approval and full approval, the company said.

Topline data to support an application for accelerated approval is expected in Q2 of 2027, ProKidney ( PROK ) said, adding that nearly half of the required patients have been enrolled so far.

The company also said it will provide updated guidance in H1 of 2026 on the timing of the release of the confirmatory readout.

Shares of the company were up over 10% in recent premarket activity Tuesday.